Erchonia FX-405 Laser for Gum Disease

(R-GUM Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Erchonia Corporation

Disqualifiers: Gingival recession, Oral cancer, HIV, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: Unknown

Duration: 8 months

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must not engage in any other treatments for periodontitis outside the study during your participation.

What data supports the effectiveness of the Erchonia FX-405 Laser treatment for gum disease?

Research on similar lasers, like the Er:YAG laser, shows they can effectively treat gum disease by removing bacteria and calculus (hardened plaque) and improving gum health. This suggests that the Erchonia FX-405 Laser might also be effective for gum disease. ^{1 2 3 4 5}

Is the Erchonia FX-405 Laser safe for use in humans?

Research on similar lasers, like the Er:YAG laser, shows that when used with the right settings, they generally do not cause harmful effects on tissues, suggesting they can be safe for human use. ^{6 7 8 9 10}

How does the Erchonia FX-405 Laser treatment for gum disease differ from other treatments?

The Erchonia FX-405 Laser treatment for gum disease is unique because it uses a specific type of laser technology, likely similar to the Er:YAG laser, which has been shown to effectively treat both hard and soft tissues in the mouth. This laser treatment can precisely target and treat affected areas, potentially offering a less invasive and more precise alternative to traditional surgical methods. ^{1 2 3 11 12}

What is the purpose of this trial?

The purpose of this clinical study is to determine the effectiveness of the Erchonia® FX-405 (manufactured by Erchonia Corporation (the Company) in providing a noninvasive adjunctive treatment in combination with periodontal scaling and root planing for improving the treatment of periodontal disease.

Eligibility Criteria

This trial is for individuals with periodontitis, including those with diabetes-related gum issues. Participants should need treatment for their gum disease and be able to undergo procedures like scaling and root planing.

Inclusion Criteria

Subject has voluntarily signed a written informed consent form

I do not have aggressive gum disease.

Subject agrees to refrain from engaging in any other treatments for periodontitis outside the scope of this study during participation

Exclusion Criteria

Pregnant or intending to become pregnant in the next 8 months

Currently enrolled in a clinical study of an investigational drug or device

My gum recession is not caused by gum disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the active Erchonia FX-405 laser treatment or a placebo laser, in combination with periodontal scaling and root planing

8 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Erchonia® FX405

Trial Overview The study tests the Erchonia FX-405 laser's effectiveness as an additional treatment alongside standard care (scaling and root planing) in improving periodontal disease outcomes compared to a placebo laser.

Participant Groups

Group I: Erchonia® FX405 Active Control 1 Intervention

The Erchonia® FX405 is made up of (3) 6405 nanometers red laser diodes and (1) 405 nanometers violet laser diode mounted in a robotic scanner device.

Group II: Placebo Laser Placebo Group 1 Intervention

The Placebo Laser has the same appearance as the Erchonia® FX405 but does not emit any therapeutic light.

Who Is Running the Clinical Trial?

Erchonia Corporation

Lead Sponsor

Trials

45

Recruited

2,100+

Findings from Research

The study involved 30 patients with grade II bifurcation lesions of chronic periodontitis, showing that treatment with Er: YAG laser combined with subgingival scaling significantly reduced pocket depth (PD) more than traditional scaling alone at both 12 and 20 weeks post-treatment.

Er: YAG laser treatment was found to be safe and effective, demonstrating significant improvements in periodontal clinical indexes, indicating its clinical value in managing chronic periodontitis with bifurcation lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical evaluation of Er:YAG laser in the treatment of grade Ⅱ periodontitis with bifurcation lesions]. Wu, YZ., Zhou, Y., Mei, YM., et al.[2022]

The Er:YAG laser treatment significantly altered the surface characteristics of dentin, creating a rough and irregular profile that affected cell adhesion and growth, particularly reducing the adhesion of human primary osteoblastic cells (hOBs).

While both periodontal ligament fibroblasts (PLFs) and hOBs proliferated on untreated dentin, PLFs showed better adhesion to the treated dentin, suggesting that the laser treatment may create a more favorable environment for PLF growth compared to hOBs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of laser-induced dentin modifications on periodontal fibroblasts and osteoblasts: a new in vitro model. Galli, C., Passeri, G., Cacchioli, A., et al.[2016]

The Erbium:YAG (Er:YAG) laser is a promising tool for periodontal treatment, showing effective results in soft and hard tissue ablation, including the removal of granulation tissue and gingival discoloration.

This laser not only minimizes damage during procedures but also promotes faster healing and has a bactericidal effect, making it beneficial for plaque and calculus removal and implant maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential applications of Erbium:YAG laser in periodontics. Ishikawa, I., Aoki, A., Takasaki, AA.[2022]

The erbium family of lasers demonstrates effective calculus removal and has a proven antibacterial action, making it a valuable tool in periodontal therapy.

These lasers cause minimal removal of root substance while promoting cell attachment, suggesting they can enhance root surface bio-modification when used alongside conventional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Root Surface Bio-modification with Erbium Lasers- A Myth or a Reality?? Lavu, V., Sundaram, S., Sabarish, R., et al.[2022]

In a study involving 21 patients, both Er:YAG and diode lasers effectively treated gingival hyperpigmentation, but the diode laser resulted in less postoperative discomfort and pain.

The Er:YAG laser caused deeper tissue injury and delayed healing compared to the diode laser, suggesting that the diode laser may be a safer and more comfortable option for patients undergoing this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of photoablative efficacy of erbium: yttrium-aluminium-garnet and diode laser for the treatment of gingival hyperpigmentation. A randomized split-mouth clinical trial. Giannelli, M., Formigli, L., Bani, D.[2014]

In a clinical trial with 28 participants, treatment with diode laser significantly reduced dentin hypersensitivity (DH) to evaporative stimuli, showing a 25.4% reduction compared to only 17.1% for fluoride and 2.9% for placebo.

Fluoride treatment did not significantly affect DH levels, indicating that diode laser therapy is a more effective option for managing sensitivity related to gingival recession.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of diode laser and fluoride on dentin hypersensitivity treatment: A randomized single-blinded clinical trial. Pantuzzo, ÉS., Cunha, FA., Abreu, LG., et al.[2022]

In a study involving 44 patients, both a resin-based desensitizer and an experimental glass-ionomer effectively reduced cervical dentin sensitivity over a 12-month period, but the glass-ionomer showed significantly better results at all follow-up points.

While the glass-ionomer treatment resulted in lower sensitivity scores, it also had some drawbacks, such as overhanging margins that could lead to plaque accumulation and gingivitis, yet it still maintained lower sensitivity levels compared to baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a resin-modified glass-ionomer liner for cervical dentin hypersensitivity treatment. Tantbirojn, D., Poolthong, S., Leevailoj, C., et al.[2015]

The erbium: yttrium, aluminum, and garnet (Er:YAG) laser, when combined with a fluorescent calculus detection system, effectively removed subgingival calculus from periodontally diseased root surfaces, achieving results comparable to traditional scaling and root planing (SRP) without causing surface damage.

In contrast, the diode laser (DL) caused significant damage to the root surfaces, including crater formation, and was ineffective for calculus removal, highlighting its unsuitability for this purpose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo and in vitro effects of an Er:YAG laser, a GaAlAs diode laser, and scaling and root planing on periodontally diseased root surfaces: a comparative histologic study. Schwarz, F., Sculean, A., Berakdar, M., et al.[2022]

In a study involving 80 infected root canals in rats, Er:YAG laser irradiation at lower energy levels (34 mJ/pulse) showed no inflammation or damage to periodontal tissues, indicating its safety for use in root canal treatments.

Higher energy levels (68 and 102 mJ/pulse) resulted in mild to severe inflammation and root surface resorption, suggesting that careful selection of laser parameters is crucial for minimizing thermal damage during root canal preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histological examination of experimentally infected root canals after preparation by Er:YAG laser irradiation. Kimura, Y., Tanabe, M., Imai, H., et al.[2021]

Using Er:YAG laser irradiation at lower energy levels (34 mJ/pulse) during root canal preparation showed no inflammation or damage to periodontal tissues in rats, indicating its safety when appropriate parameters are used.

In contrast, higher energy levels (102 mJ/pulse) resulted in significant inflammation and root surface resorption in 80% of cases, highlighting the importance of selecting the right laser settings to minimize adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects on periradicular periodontal tissues of root canal irradiation with Er:YAG laser in rats. Kimura, Y., Yonaga, K., Murakoshi, M., et al.[2015]

The Er:YAG laser effectively removed gingival melanin pigmentation in five patients, showing fast healing and healthy tissue appearance within one week after treatment.

After three months, complete healing was observed with no deformities or recession in most cases, indicating that this method is safe and provides significant aesthetic improvement, although there was a slight recurrence in one patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esthetic treatment of gingival melanin hyperpigmentation with Er:YAG laser: short-term clinical observations and patient follow-up. Rosa, DS., Aranha, AC., Eduardo, Cde P., et al.[2019]

The use of Er:YAG laser in simultaneous surgery for periapical granuloma and infraossal defects showed promising results, suggesting it may improve the survival rate of periodontally affected teeth with periapical lesions.

In this case report, the laser was effectively used for various surgical procedures, including flap dissection and granulation tissue removal, with successful outcomes observed over an 18-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous Perio-endo Surgery with ER:YAG Laser and Bone Xenograft. A Case Report. Krastev, B., Filipov, I.[2021]

References

1. China pubmed.ncbi.nlm.nih.gov

[Clinical evaluation of Er:YAG laser in the treatment of grade Ⅱ periodontitis with bifurcation lesions]. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of laser-induced dentin modifications on periodontal fibroblasts and osteoblasts: a new in vitro model. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Potential applications of Erbium:YAG laser in periodontics. [2022]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Root Surface Bio-modification with Erbium Lasers- A Myth or a Reality?? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Comparative evaluation of photoablative efficacy of erbium: yttrium-aluminium-garnet and diode laser for the treatment of gingival hyperpigmentation. A randomized split-mouth clinical trial. [2014]

6. India pubmed.ncbi.nlm.nih.gov

Effectiveness of diode laser and fluoride on dentin hypersensitivity treatment: A randomized single-blinded clinical trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a resin-modified glass-ionomer liner for cervical dentin hypersensitivity treatment. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

In vivo and in vitro effects of an Er:YAG laser, a GaAlAs diode laser, and scaling and root planing on periodontally diseased root surfaces: a comparative histologic study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Histological examination of experimentally infected root canals after preparation by Er:YAG laser irradiation. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Effects on periradicular periodontal tissues of root canal irradiation with Er:YAG laser in rats. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Esthetic treatment of gingival melanin hyperpigmentation with Er:YAG laser: short-term clinical observations and patient follow-up. [2019]

12. Bulgaria pubmed.ncbi.nlm.nih.gov

Simultaneous Perio-endo Surgery with ER:YAG Laser and Bone Xenograft. A Case Report. [2021]